Mechanical ventricular assistance cup

ABSTRACT

An improved mechanical ventricular assistance cup for assisting a heart in the performance of its pumping operations or for aiding the heart in achieving normal pumping rhythm, which cup assembly is provided with a semiflexible or inflatable powder shell to reduce the size of the incision required for implanting the mechanical pump and further being comprised of constituent materials which render the cup effectively indestructible, make the cup compatible with blood and body tissue and further act to provide a sturdier cup structure.

United States Patent Peter Schiff I RD. #2, Lambertville, NJ. 08530840,253

July 9, 1969 Oct. 19, 1971 Inventor Appl. No Filed Patented MECHANICALVENTRICULAR ASSISTANCE CUP 1] Claims, 10 Drawing Figs.

US. Cl l28/24.5, 128/64 Int. Cl A6lh 29/00 Field ofSearch 128/24, 24.2,24.5, 44, 64

References Cited UNITED STATES PATENTS 3/1968 Heid et al.

3,034,501 5/1962 Hewson 128/64 3,455,298 7/1969 Anstadt 128/64 3,478,73711/1969 Rassman 128/64 Primary Examiner-L. W. Trapp Attorney-Ostrolenk,Faber, Gerb & Solfen ABSTRACT: An improved mechanical ventricularassistance cup for assisting a heart in the performance of its pumpingoperations or for aiding the heart in achieving normal pumping rhythm,which cup assembly is provided with a semiflexible or inflatable powdershell to reduce the size of the incision required for implanting themechanical pump and further being comprised of constituent materialswhich render the cup effectively indestructible, make the cup compatiblewith blood and body tissue and further act to provide a sturdier cupstructure.

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PATENTEDUCT 19 IHYI 3613.67 2 sum 2 ur 3 PETER SCH/FF INVILN'I'UR.

drawn/n; 575:4: fete: f inrlv MECHANICAL VENTRICULAR ASSISTANCE CUPConventional mechanical ventricular assistance cups, for example, of thetype described in copending application Ser. No. 785,652, filed Dec. 20,1968 are normally comprised of a rigid shell or cup member having alarge opening for receiving and positioning the heart therein and atleast first and second ports for applying negative pressure andpulsatile pressure, respectively, to retain the heart within the cup andto provide assistive pumping action. When mechanical ventricularassistance cups of this general type are employed, the rigid shellstructure requires a relatively large surgical incision to be made inthe patient in order to insert and position the cup assembly around theventricles of the heart. In addition thereto, it is frequently desirableto implant such a circulator assistance cup for long periods of time andhave the cup remain in a dormant state around theheart during itsimplantation period until it becomes necessary to mechanically activatethe cup so as tosupport any temporary or long term inadequacy of thenatural heart pumping function. In such instances, the rigid assistancecup severely impairs the natural heart function when the assistance cupis not mechanically activated.

The invention is characterized by providing a mechanical ventricularassistance cup assembly which is made more readily insertable through arelatively small surgical incision by the provision of a semiflexibleouter shell. In addition, the use of an inflatable outer shell as onealternative embodiment advantageously adapts the cup for long termimplantations wherein the cup may remain dormant and in an unimpairingstate until it is inflated for mechanical assistance.

BACKGROUND This invention relates to improvements in mechanicalventricular assistance so as to yield a more flexible, versatile andeffectively indestructible cup assembly. Mechanical ventricularassistance may generally be utilized to provide either constant shortterm circulatory support or partial periodic longterm circulatorysupport.

When mechanical ventricular assistance devices are used in either of theabove-mentioned modes, it is desirable to be able to implant the devicewith a surgical incision of minimal size. In order to reduce the size ofthe surgical incision, a semiflexible cup shell is utilized, which shellis of sufficient rigidity to aid in mechanical assistance during thediastole cycle and yet be manually compressible for insertion of the cupthrough a small surgical opening. In addition, the cup has aconstruction which permits recording of an electrocardiogram in spite ofthe electrical insulating properties of the cup as well as providinglong-term reliability as a result of its unique mechanical design.

If such as cup assembly is utilized in a partial circulatory support orin a periodic long-term circulatory support mode, a rigid shell wouldseverely interfere with the natural pumping of the heart such as, forexample, in cases where the heart, when enlarged, would attempt toincrease its size beyond the size of the rigid cup and thereby berestrained by the cup. As a result thereof, the cup shell is formed of aflexible material and is of such a nature, when dormant, as to besimilar to the sack or periocardium which normally surrounds the heart.Upon demand, the sacklike assistance device must be capable of beingmade rigid so that it will support not only the systole action, but alsothe diastole or filling action of the ventricles.

The present invention is comprised of a mechanical ventricularassistance device having a flexible cup shell with the first largeopening provided for receiving the ventricles of the heart. A secondopening provided at or near the apex of the cup is adapted to receive anegative pressure of an amplitude sufficient to retain the heart withinthe cup at least during 1 those periods in which the mechanicalventricular assistanc device is being activated. I A flexible shell ormembrane is positioned within the interior of the cup and is sealedabout the margin of the cup large opening and in the region of theopening located near the apex of the cup so as to form a hollowenclosure which communicates with a third cup opening for receivingalternating positive and negative (pulsatile) pressure to alternatelyexpand and contract the flexible membrane and thereby impart a pumpingaction to the heart ventricles.

A conductive member positioned within the interior of the cup andadaptedto engage the heart ventricles is electrically connected through asuitable lead to enable electrocardiograms of the heart action to betaken when the cup is either in its dormant or active state.

The flexibility of the cup shell permits it to be manually squeezed orcontracted together so as to reduce its overall size during insertionand thereby reduce the size of the incision required for insertion.

The flexible membrane is preferably formed of a material having a hightensile strength was to be capable of being easily collapsed while beingsubstantially incapable of being stretched. Theflexible membrane ispreferably secured within the interior of the cup in the region of theapex by suitable adhesive means and is sandwiched between the metallicelectrode and the semiflexible cup shell. The remaining seal between theflexible diaphragm and the cup is obtained through the use of anadhesive material which adheres a marginal portion of the flexiblemembrance along the marginal exterior surface of the cup shell in theregion of the cup shell large opening so as to eliminate tearingstresses at the seals between shell and membrane and causing theflexiblemembrane to experience only tensile or pulling stresses. Themeof a flexible membrane having a high tensile strength renders the shellstructure substantially indestructible due to the nature of the sealsemployed.

The cup shell may alternatively be formed of a ribbed inflatablestructure having a plurality of internally inflatable chamberspreferably communicating with one another for the receipt of airpressure therein so as to form a substantially rigid shell structurewhen inflated and a highly flexible shell structure when deflated and inthe dormant state. This structure also serves to minimize the size ofthe surgical incision required during implantation of the device.

It is therefore one object of the present invention to provide amechanical ventricular assistance cup for assistinga heart in theperformance of its pumping operations for aiding the heart in achievingnormal pumping rhythm.

Another object of the present invention is to provide a novel mechanicalventricular assistance assembly having a cup shell which is flexible andinflatable to facilitate implantation within the body of a patient andnecessitating only a minimal size incision for insertion thereof.

Still another object of the present invention is to provide a novelmechanical ventricular assistance assembly having a cup shell which isflexible and inflatable to facilitate implantation within the body of apatient and necessitating only a minimal size incision for insertionthereof and whereby the flexible membrane of the assembly which assistsin the pumping action is formed of materials and is of a design such asto render the cup totally compatible with body tissue and substantiallyindestructible.

These as well as other objects of the present invention will becomeapparent when reading the accompanying description and drawings inwhich:

FIG. 1 is a perspective view showing one mechanical ventricularassistance cup assembly designed in accordance with the principles ofthe present invention.

FIG. 2 is a sectional view of the assembly shown in FIG. 1.

FIG. 3 is a perspective view of a cup assembly showing another preferredembodiment of the invention.

FIG. 4 is a sectional view of the cup assembly of FIG. 3.

FIG. 5 is a perspective view showing another preferred embodiment of thecup assembly of the present invention.

FIG. 6 is a sectional view of a portion of the cup assembly of FIG. 5looking in the direction of arrows A-A.

FIG. 7 is a perspective view of a single tubular, inflated ring portionof the assembly of FIG. 3 useful in describing the effectiveness of thecup assembly shown therein.

FIG. 8 shows a portion of the cup assembly of FIG. 2, for example, indetail for purposes of explaining the structural advantages of theinvention.

FIG. 8a shows a detailed sectional view of a portion of a conventionalcup assembly for purposes of further explaining the advantages of thecup structure of the present invention.

FIG. 9 shows a sectional view of a portion of the flexible membranewhich may be employed in the present invention.

FIG. I illustrates a perspective view of a mechanical ventricularassistance cup. The assembly is comprised of a semiflexible cup shell 21which may, for example, be formed of a rubber or plastic material havinga fibrous matrix so as to prevent the cup material from being stretchedwhile being yieldable and capable of being bent or contracted. A largeopening 21a is provided at the top end of the cup shell 21 as designatedby numeral 21a, andis adapted to receive the ventricles of the heart.The apex of the cup is provided with an opening, as shown best in FIG.2, communicating with a fitting '10 which acts to secure a hollowtubular member 14 to the apex opening of the cup. A sustained vacuum ornegative holding pressure is applied through tube 14 t fitting 10 toretain the ventricles of the heart within the cup interior. Pulsatile(i.e. alternating positive and negative) pumping pressures are appliedthrough a hollow tubular member 11 and a fitting 12 to an openingprovided intermediate the openings 21a and 21b. This opening 21c, whichis provided along one surface of the cup, communicates with an enclosedinterior volume to be more fully described. A lip member 38 maintains aseal between the cup assembly and the AV groove, not shown, of theheart.

FIG. 2 shows the internal structure of the cup assembly in greaterdetail and includes an electrode member adapted to permitelectrocardiogram recording, fibrillation and defibrillation in themanner set forth in detail, for example, in copending application Ser.No. 785,652, filed Dec. 20, I968. For example, FIG. 2 of this copendingapplication shows the particular pressure sources employed forsustaining the heart within the cup and for providing the assistivemechanical pumping action.

The cup assembly further incorporates a flexible shell or membrane 35having a construction which insures against the possible bursting of themembrane due to weaknessesin the design or material of the liner. Thelip 38 surrounding the large opening 21a of the cup is secured to liner35 such as, for example, by a heating-sealing or by a suitable adhesive.Liner 35 extends at its upper 'end about the margin of the cup definingopening 21a and the marginal portion of the liner extends downwardlyalong the outer surface of the cup and is secured to the marginalexterior portion of the cup 21 immediately adjacent opening 21a. Liner35 is preferably cemented by a suitable cement or adhesive applied at22.

Liner, or membrane, 35 is further cemented in the region of the apex ofthe cup wherein one surface of liner 35 is cemented at 19 to the portion21d of reduced cup thickness and is further cemented in the region 190to the convex surface of stainless steel electrode 18 so that the liner35 is sandwiched between electrode 18 and the reduced thickness portion21d of cup 21. A wire 15 is electrically connected to the stainlesssteel electrode 18 and extends through a suitable opening 2Ie providedin the reduced thickness portion 21d of cup 2] for connection toperipheral circuitry. For example, this electrode may be employed tocouple the signals detected from the heart ventricle to anelectrocardiogram. As was previously mentioned, the material of cupshell 21 is preferably of flexible nonstretchable material which may be,for example, a plastic material or a combination of a plastic or rubbermaterial in conjunction with a fiberlike matrix embedded therein.

In operation, the negative pressure applied through tubular member 14retains the heart ventricles within the cup assembly. Alternatingpositive and negative pressure pulses applied through tubular member 11cause the flexible membrane 35 to alternately expand in the manner shownin FIG. 2 and contract so as to move closer to the interior surface ofcup 21,

thereby assisting the heart in the performance of its pumping action.

Another preferred embodiment of the present invention is shown in FIGS.3 and 4 wherein the inflatable shell structure is comprised of acontinuously helically wound tubular coil 52. The coil 52 forms theouter shell of the cup and is joined at its lower edge 52a to a solid,substantially rigid cup portion 21d. It should be noted that the bottomportion of the cup assembly is substantially identical to that shown inFIG. 2 wherein like elements have been designated by like numerals. Atubular member 57 of small diameter is connected to the coiled tubularstructure 52 and serves to selectively either inflate or deflate coiledsection 52 to form a rigid cup structure. In cases where the structureis deflated, the upper shell portion may lie dormant when implanted intothe body of a patient in cases where the pumping action of the patientis satisfactory and requires no mechanical pumping assistance.

The sectional view of FIG. 3, shown in FIG. 4, depicts the cup lipmember 38 as being bonded to the exterior surface of liner 35 which isstretched about the marginal exterior portion of the tubular coil 52 ina manner similar to that shown in FIG. 2. The liner is cemented in theregion 22 which comprises the marginal exterior surface of the outer cupshell immediately surrounding opening 21a. Adjacent coilsof elongatedhelically coiled tube 52 are preferably cemented to one another by asuitable adhesive or alternatively may be heat-sealed to one another.

The design principles employed in the attachment of liner 35 in FIGS. 1through 4 provide extremely high tensile strength and substantiallyeliminate any tear stresses in the structure in a manner to be morefully described.

FIG. 8a shows a sectional view of an upper cup portion of a conventionalcup assembly such as, for example, of the type described in theabove-mentioned application Ser. No. 785,652. As shown in FIG. 8a, theliner or membrane 35 is joined to the upper marginal interior surfaceportion 220 of cup 22, which marginal portion is immediately adjacentthe large cup opening 21a. The portion 35a of membrane 35 is bonded tomarginal portion 22a of the rigid glass cup by a suitable adhesive 36.Assuming that a membrane 35 of high tensile strength is employed, themembrane itself, although bendable, will undergo almost no stretching.Thus, when the hollow interior region defined by membrane 35 and cup 21is filled with a positive pressure pulse, the high-tensile strength ofthe membrane places a strong tear stress upon the bonding cement 36,causing the liner portion 35a to be pulled away from glass shell 22 inthe direction substantially as shown by arrow 37. The application ofrepeated positive pressure pulses over prolonged periods of time willweaken the bonding agent and thereby tear the membrane away frommarginal portion 22 a of the cup shell.

FIG. 8 shows the upper marginal portion of the cup structures of FIGS. 2or 4, for example, wherein the membrane 35 formed of a material havinghigh-tensile strength extends upwardly over the lip of the cup shell anddownwardly along its outer marginal portion where it is bonded in theregion 22 by a suitable bonding cement 36. Dotted line portion 35 showsthe membrane in the collapsed state. When a positive pressure pulse isapplied through tubular member 11, the membrane moves to the expandedposition shown by the solid line portion 35. Due to the high tensilestrength of the membrane, substantially no tear stress is placed uponthe bond between the membrane and the liner. Alternatively, the tensilestress as represented by arrow 38a is distributed substantially equallyover the entire bond between membrane 35 and cup 21. Thus, even afterrepeated application of positive pressure pulses over prolonged periodsof time, the bond between liner and shell will be unaflected, yielding asubstantially indestructible structure.

In a similar manner, the sandwiching of the bottom portion of liner 35between electrode 18 and reduced thickness shell portion 21d (by asuitable bonding cement) similarly distributes the pulling stresssubstantially equally along the length of the membrane portionsandwiched between electrode 18 and shell portion 21d so as to provide asubstantially indestructible structure in the apex region of the cup.

The flexible characteristics of either shell 21 of FIG. 2 or coiledshell 52 of FIG. 4 permits the cup to be squeezed (for example, by thehand) so as to be inserted through a relatively small surgical incision.If desired, the fitting 12 shown in FIGS. I through 4 may be replaced bya right-angle" fitting of the type shown by fitting of FIGS. 1 through 4to further reduce the amount of clearance required for insertion andimplantation into the body of a patient. Upon demand, the cup shown inFIGS. 3 and 4 may be made rigid by the injection ofa high-pressure pulseapplied through tube 57. Alternatively, the cup shown in FIGS. 3 and 4may be caused to remain in a dormant state by removal of the pressurepulse, thereby deflating the coiled cup section. When in a dormantstate, the cup assembly provides minimal interference to a heartunassisted by the mechanical pumping action.

FIG. 7 serves to explain the reason why the coiled cup assembly willremain rigid when in the inflated condition. FIG. 7 shows in schematicfashion one full turn of the coiled cup 52. When inflated, the airpressure within each coil will be substantially equally distributedthroughout. Thus, the pressure along the interior surface of the coilshown in FIG. 7 will be equal to Kh'ird, where d is equal to thediameter of the coil shown in FIG. 7; h is equal to the height of theinterior surface of the coil (assuming the coil to be of a squarecross-sectional configuration for purposes of simplifying thedescription set forth herein); and where K is equal to a constant. Thepressure along the outer wall of the single loop of coil is equal toKh(d+ Ar) wherein (d+Ar) is equal to the diameter of the outer wall ofthe single loop coil. Since the surface area of the outer wall of thesingle loop of coil is greater than the surface area of the inner wallof the single loop of coil (due to the increased diameter d-l-Ar), theequally distributed air pressure will cause the coiled shell portion 52to assume the shape as shown best in FIG. 3, which structure will remainsubstantially rigid when inflated.

FIGS. 5 and 6 show another alternative embodiment of the presentinvention wherein the helically coiled portion of FIG. 3 is replaced bya vertically ribbed inflatable portion 52' which is comprised of firstand second plastic sheets 53 and 54 (shown best in FIG. 6) which arejoined by a suitable adhesive 55 at regularly spaced intervals to formthe vertical ribs 56. Inflating of the structure may occur in a mannersimilar to that shown in FIGS. 3 and 4 wherein a positive pressure pulseis applied through narrow diameter tube 57 to fill the inflatablestructure with air. Each of the hollow interior portions 58 may bejoined to adjacent hollow interior portions by providing narrowcommunicating passageways 59 arranged in alternating fashion near thebottom edge of the structure 52' and providing similar narrowcommunicating portions (not shown) near the top edge of structure 52'interspersed with portions 59 so that a positive pressure pulse appliedthrough narrow diameter tube 57 will pass through each of the hollowinterior sections 58 in a serpentine fashion, until the air pressure isequally distributed throughout interior hollow sections 58. Although theribs 56 are shown as being vertically aligned in FIG. 5, it should beunderstood that these ribs may be arranged in horizontal fashion similarto the coiled tubular arrangement shown in FIG. 3. Whether vertically orhorizontally aligned ribs are employed, the shell structure 52 will forma substantially rigid structure when inflated for the reasons as setforth in connection with the description of FIG. 7. Thus, the structureof FIG. 5 is equally as versatile as that shown in FIGS. I and 3 insofaras being capable of being retained in either a dormant or active statewhile implanted within a patient.

The flexible membrane 35 shown in the present invention has a furtheradvantage of the membrane structure 35 employed in conventional cupassemblies (for example, of the type described in copending application785,652) in that the liner, by being bonded to the outside of the cup,increases the effective pumping area of the diaphragm as compared withconventional design, which has the liner bonded to the inside of theshell just below the cup lip 38. For this reason, higher pumping volumesand pressures are obtainable with the structure described herein.

FIG. 9 shows one preferred embodiment for the cup liner 35 wherein theliner may be comprised of a sheet of material 60 having high-tensilestrength. Some materials which have been found advantageous for use inthis application are polyurethane which has a tensile strength ofapproximately 7,000 p.s.i. or Mylar which has a tensile strength ofabout 40,000 p.s.i. Such materials are substantially nonstretchable whenemployed as a membrane in the present invention and are, therefore,practically indestructible. However, these materials, if sharply bent orcreased, will deform along the crease and possibly develop a weaknessalong the crease which may be caused to tear after prolonged useessentially due to the repeated application of positive and negativepressure pulses to.

the cup assembly.

In addition thereto, it is most advantageous to provide a cup assemblywhose materials are most favorably compatible with body tissue and bloodcells. It has been found that silicone rubber exhibits excellentcompatibility withbody tissue and blood. However, the tensile strengthof silicone rubber is of the order of 400 p.s.i., making it highlystretchable as compared with polyurethane or Mylar. Thus, in order tomake most advantageous use of these materials, the sheet 60 ofhigh-tensile strength material shown in FIG. 9 is coated along bothsurfaces thereof by silicone rubber layers 61 and 61a, which coatingprocess may be performed, for example, by dipping the high-tensilestrength sheet 60 into a bath of silicon rubber in liquid form containedin an enclosure having a moisture-free atmosphere. The dipping operationmay be so timed and so performed so as to preferably fonn a coating ofapproximately 3 mils thickness on a sheet of high-tensilestrengthmaterial having a thickness of the order of 0.5 to l mil. Likewise, thecup assembly 22 or 52 may be dipped in the liquid silicone rubber toprovide a similar coating thereon. Altemative approaches which may betaken consist either of coating the membrane 35 on both sides thereof,as shown in FIG. 9, and then bonding the membrane to the cup shell, or,alternatively, initially bonding the cup membrane to the cup shell andthen dipping the entire structure within a liquid bath of siliconerubber. The latter method can be seen to provide a silicone rubbercoating on only the exposed surface of the membrane which has been foundto be satisfactory, since only this surface will be exposed to bodytissue. Coating the entire exposed surface of the cup shell 22 or 52renders it compatible with body tissue. The lip 38 of the shellstructure may also be formed of silicone rubber of a thickness of theorder of 40 mils. Alternatively, the membrane 35 may be formedexclusively of silicone rubber of a thickness of the order to 30 mils.

It can be seen from the foregoing description that the present inventionprovides a novel mechanical ventricular assistance cup assembly which iscapable of being contracted when implanted within the body of a patientto permit incisions of minimal size for insertion thereof wherein thecup assembly may lie dormant for prolonged periods of time whenimplanted so as to have no impairing effect upon normal heart pumpingaction, and may further be inflated to form a substantially rigid cupstructure upon demand when assistive mechanical pumping action isdesired.

Although this invention has been described with respect to its preferredembodiments, it should be understood that many variations andmodifications will now be obvious to those skilled in the art, and it ispreferred, therefore, that the invention be limited not by the specificdisclosure herein but only by the appended claims.

The embodiments of the invention in which an exclusive privilege orproperty is claimed are defined as follows:

I. A cup assembly for use in applying mechanical assistivc pumpingaction to the heart comprising:

a substantially flexible nonstretchable cup-shaped member having aconfiguration generally conforming to the configuration of at least aportion of the heart;

said cup having a first substantially large diameter opening forreceiving a portion of the heart and positioning said portion within theinterior of the cup, and having second and third small diameteropenings;

at least one of said second and third openings being located at the apexof said cup which is furthest removed from said first opening and theremaining one of said second and third openings being located along thesurface of said cup at a position intermediate said first opening andthe opening at the apex of said cup;

a flexible liner being positioned within said cup and having aconfiguration substantially conforming to the interior of said cup whenthe liner is in an unstressed condition;

a first continuous marginal edge of said liner being positionedagainstthe marginal exterior surface portion of said cup which surrounds saidfirst opening;

a second continuous marginal portion of said liner being positionedagainst the interior surface of said cup and adjacent to and surroundingthe opening in said cup provided in the cup apex;

bonding means for securing the continuous marginal edges of said linerto the exterior and interior cup surfaces, respectively, located in theregion of said first opening and the opening located in the cup apex;

said liner cooperating with said cup to form a hollow interior regioncommunicating with said remaining one of said second and third openings,which hollow region is adapted to receive pulsatile pressure to causethe liner to expand and contract and thereby assist the heart in theperformance of its pumping activity; said flexible cup beingcontractable to reduce the cup size when implanted in the body of apatient to minimize the size of the required incision.

2. A device of the type described in claim 1 further comprising ametallic electrode positioned within the interior of the cup in theregion of the cup apex;

means for bonding said electrode to the marginal portion of said linersurrounding the cup apex.

3. The device of claim 1 further comprising a tube connected to theopening provided in the apex of the cup for communicating a sustainednegative pressure thereto for retaining said heart portion within thecup.

4. The device of claim 1 wherein a major portion of said cup extendingbetween said electrode and said first opening is comprised of aninflatable structure comprising inner and outer flexible inelasticmembers defining a hollow interior;

a narrow diameter tubular member being connected to said inflatablestructure to fill said inflatable structure with air and thereby form asubstantially rigid cup configuration when mechanical assistive pumpingaction is required.

5. The device of claim 4 wherein said inflatable structure is comprisedof an elongated tubular member being coiled to form the configuration ofthe cup portion extending between said electrode and said first opening;

bonding means for joining adjacent exterior surface portions of saidcoiled tubular member.

6. The device of claim 4 wherein said inflatable structure is comprisedof first and second substantially flexible, nonstretchable sheets ofmaterial extending between said electrode and said first opening;

bonding means for joining said first and second sheets at spacedintervals to form spaced, substantially parallel ribs defining elongatedhollow interior portions communicating with one another to receive airunder pressure from said narrow diameter tubular member and thereby forman inflated substantially rigid cuplike configuration generallyconforming to the shape of the portion of the heart positioned therein.

7. The device of claim 6 wherein said ribs extend in a directiontransverse to the edge of the cup surrounding said first o enin 8. Thetfevice of claim 6 wherein said ribs extend in a direction substantiallyparallel to the edge of the cup surrounding said first opening to form asingular helically shaped elongated hollow interior portion.

9. The device of claim 1 wherein said liner material is a sheet offlexible material having high-tensile strength.

10. The device of claim 9 wherein the surface of said sheet makingcontact with the heart is coated with silicone rubber.

11. The device of claim 1 wherein all of the exposed surface of saiddevice is coated with silicon rubber.

1. A cup assembly for use in applying mechanical assistive pumpingaction to the heart comprising: a substantially flexible nonstretchablecup-shaped member having a configuration generally conforming to theconfiguration of at least a portion of the heart; said cup having afirst substantially large diameter opening for receiving a portion ofthe heart and positioning said portion within the interior of the cup,and having second and third small diameter openings; at least one ofsaid second and third openings being located at the apex of said cupwhich is furthest removed from said first opening and the remaining oneof said second and third openings being located along the surface ofsaid cup at a position intermediate said first opening and the openingat the apex of said cup; a flexible liner being positioned within saidcup and having a configuration substantially conforming to the interiorof said cup when the liner is in an unstressed condition; a firstcontinuous marginal edge of said liner being positioned against themarginal exterior surface portion of said cup which surrounds said firstopening; a second continuous marginal portion of said liner beingpositioned against the interior suRface of said cup and adjacent to andsurrounding the opening in said cup provided in the cup apex; bondingmeans for securing the continuous marginal edges of said liner to theexterior and interior cup surfaces, respectively, located in the regionof said first opening and the opening located in the cup apex; saidliner cooperating with said cup to form a hollow interior regioncommunicating with said remaining one of said second and third openings,which hollow region is adapted to receive pulsatile pressure to causethe liner to expand and contract and thereby assist the heart in theperformance of its pumping activity; said flexible cup beingcontractable to reduce the cup size when implanted in the body of apatient to minimize the size of the required incision.
 2. A device ofthe type described in claim 1 further comprising a metallic electrodepositioned within the interior of the cup in the region of the cup apex;means for bonding said electrode to the marginal portion of said linersurrounding the cup apex.
 3. The device of claim 1 further comprising atube connected to the opening provided in the apex of the cup forcommunicating a sustained negative pressure thereto for retaining saidheart portion within the cup.
 4. The device of claim 1 wherein a majorportion of said cup extending between said electrode and said firstopening is comprised of an inflatable structure comprising inner andouter flexible inelastic members defining a hollow interior; a narrowdiameter tubular member being connected to said inflatable structure tofill said inflatable structure with air and thereby form a substantiallyrigid cup configuration when mechanical assistive pumping action isrequired.
 5. The device of claim 4 wherein said inflatable structure iscomprised of an elongated tubular member being coiled to form theconfiguration of the cup portion extending between said electrode andsaid first opening; bonding means for joining adjacent exterior surfaceportions of said coiled tubular member.
 6. The device of claim 4 whereinsaid inflatable structure is comprised of first and second substantiallyflexible, nonstretchable sheets of material extending between saidelectrode and said first opening; bonding means for joining said firstand second sheets at spaced intervals to form spaced, substantiallyparallel ribs defining elongated hollow interior portions communicatingwith one another to receive air under pressure from said narrow diametertubular member and thereby form an inflated substantially rigid cuplikeconfiguration generally conforming to the shape of the portion of theheart positioned therein.
 7. The device of claim 6 wherein said ribsextend in a direction transverse to the edge of the cup surrounding saidfirst opening.
 8. The device of claim 6 wherein said ribs extend in adirection substantially parallel to the edge of the cup surrounding saidfirst opening to form a singular helically shaped elongated hollowinterior portion.
 9. The device of claim 1 wherein said liner materialis a sheet of flexible material having high-tensile strength.
 10. Thedevice of claim 9 wherein the surface of said sheet making contact withthe heart is coated with silicone rubber.
 11. The device of claim 1wherein all of the exposed surface of said device is coated with siliconrubber.